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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04075071
Other study ID # 19-016084
Secondary ID IRB 19-016084
Status Terminated
Phase N/A
First received
Last updated
Start date September 12, 2019
Est. completion date May 19, 2020

Study information

Verified date August 2020
Source Children's Hospital of Philadelphia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This pilot study aims to implement and evaluate Teacher-Child Interaction Training - Universal (TCIT-U), an empirically-supported classroom-based intervention aimed at improving child behavior and social-emotional skills through strengthening teacher-child relationships at a preschool that serves children from socially and economically disadvantaged backgrounds who are at risk for behavioral health difficulties. The main objectives are to (a) examine TCIT-U's effects on teacher behavior, teachers' sense of efficacy, and child behavior problems and social-emotional skills compared to usual care (UC) and (b) explore the feasibility and acceptability of implementing TCIT-U at a diverse urban preschool.


Description:

Disruptive behaviors and social-emotional skill deficits are common problems in early education settings and contribute to the high rates of preschool suspensions and expulsions. While teachers serve a critical role in children's behavioral health, they often lack evidence-based training in strategies that could improve child behavior and promote social-emotional skills. The goal of this project is to implement and evaluate Teacher-Child Interaction Training - Universal (TCIT-U), an empirically-supported classroom-based intervention aimed at improving child behavior and social-emotional skills through strengthening teacher-child relationships at a preschool that serves children from socially and economically disadvantaged backgrounds who are at risk for behavioral health difficulties.

The main objectives are to (a) examine TCIT-U's effects on teacher behavior, teachers' sense of efficacy, and child behavior problems and social-emotional skills compared to usual care (UC) and (b) explore the feasibility and acceptability of implementing TCIT-U at a diverse urban preschool.

This pilot study is a nonrandomized clinical trial comparing TCIT-U to a UC control group at urban preschool. Teachers in the intervention group will participate in TCIT-U. TCIT-U and UC teachers will complete measures at baseline, post-intervention, and end-of-the-school-year follow-up. All teachers will be observed for their TCIT-U skill use at baseline, mid-intervention, post-intervention, and follow-up. Qualitative interviews will be conducted with educational staff at follow-up to examine feasibility and acceptability data.

Participants will be eight teachers and approximately 80 children from four preschool classrooms in Philadelphia. Educational staff will also be invited to participate in qualitative interviews. Staff must speak English to participate. There is no exclusion criteria for children.

Four teachers from two Head Start classrooms will participate in TCIT-U. TCIT-U is an empirically-supported intervention aimed at strengthening teacher-child relationships and improving child behavior and social-emotional skills. TCIT-U includes group didactic and individualized coaching sessions. Four teachers from two other classrooms will serve as the UC control group.

Teacher behavior will be coded during live classroom observations. Teacher-reported questionnaires will measure teachers' sense of efficacy and child behavior and social-emotional skills. Qualitative interviews and satisfaction surveys will explore the feasibility and acceptability of implementing TCIT-U. Fidelity checklists will be completed by the TCIT-U Trainer and expert consultants to document intervention fidelity.


Recruitment information / eligibility

Status Terminated
Enrollment 70
Est. completion date May 19, 2020
Est. primary completion date February 5, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years and older
Eligibility Teachers' Inclusion Criteria:

- Serve as a head, co-, and/or assistant teacher in a Head Start or PreK Counts classroom at the participating early childhood education center.

- Speak and read English proficiently.

- Provide written informed consent.

Teachers' Exclusion Criteria: Do not speak and read English proficiently.

Children's Inclusion Criteria:

- Enrolled in one of the participating Head Start or PreK Counts classrooms prior to baseline evaluations.

- Aged 3 through 5 years old.

- Provided an informational letter about the study to their parents.

Children's Exclusion Criteria: There are no exclusion criteria for children.

Educational Staff's Inclusion Criteria (qualitative interviews):

- Participated in or observed TCIT-U training and/or serve as a classroom-based (e.g., assistant, behavioral specialist) or administrative (e.g., center director) staff for the classrooms participating in TCIT-U.

- Speak and read English proficiently.

- Provide written informed consent.

Educational Staff's Exclusion Criteria (qualitative interviews): Do not speak and read English proficiently.

Study Design


Intervention

Behavioral:
Teacher-Child Interaction Training - Universal
Teacher-Child Interaction Training - Universal (TCIT-U) is an empirically-supported classroom-based intervention designed to strengthen teacher-child relationships, reduce and prevent child behavior problems, and promote social-emotional skills. TCIT-U is based in behavioral and attachment principles and was developed as a modification of Parent-Child Interaction Therapy (PCIT), an evidence-based treatment with well-established support for decreasing disruptive child behaviors and parental stress with children ages two to seven years old. In TCIT-U, teachers of children, preschool through second grade, are taught and coached in skills to manage challenging classroom behaviors and improve the quality of relationships. TCIT-U is delivered to teachers through group didactic training and live individualized coaching.

Locations

Country Name City State
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Children's Hospital of Philadelphia PNC Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in Teacher-Child Interaction Coding System (TCICS) Teachers' use and maintenance of skills taught in TCIT-U will be measured using the Teacher-Child Interaction Coding System (TCICS; Budd & Stern, 2019), an observational coding system that has been used in prior TCIT-U projects and was adapted from the coding system used in PCIT (Dyadic Parent-Child Interaction Coding System, 4th edition; Eyberg, Chase, Fernandez, & Nelson, 2014). RAs, blind to study condition, will tally teachers' verbalizations (Labeled Praises, Reflections, Descriptions, Questions, Commands, and Negative Talk) during 5-minute intervals which will be conducted three times at each data collection time-point (baseline, mid-intervention, post-intervention, and follow-up). Week 1, Week 6-8, Week 12, and Month 10
Secondary Teachers' Sense of Efficacy Scale (TSES) Teachers' beliefs in their capability of influencing factors related to academic instruction and student behavior will be assessed using the Teachers' Sense of Efficacy Scale (TSES; Tschannen-Moran & Woolfolk Hoy, 2001). Teachers will rate their perceived efficacy in three areas (Student Engagement, Instructional Practices, and Classroom Management) at baseline, post-intervention, and follow-up. The rating is based on a scale of 1 (nothing), to 9 (a great deal). Week 1, Week 12, and Month 10
Secondary Devereux Early Childhood Assessment for Preschoolers, 2nd Edition (DECA-P2) Child behavior problems (e.g., noncompliance, aggression) and social-emotional skills (e.g., self-regulation) will be assessed using the Devereux Early Childhood Assessment for Preschoolers, Second Edition (DECA-P2; LeBuffe & Naglieri, 2012). The DECA-P2 is a 38-item standardized, strengths-based behavior rating scale that yields a Total Protective Factors scale (Initiative, Self-Regulation, Attachment/Relationships) and a Behavioral Concerns scale. Teachers will rate the frequency of children's behavior at baseline, post-intervention, and follow-up. Week 1, Week 12, and Month 10
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